Why Drugs are Recalled

A drug recall happens “when a prescription or over-the-counter medicine is removed from the market because it is found to be either defective or potentially harmful.” WebMD

Below are a few FDA Recall definitions:

Correction: means repair, modification, adjustment, relabeling, destruction, or inspection of a product without its physical removal to some other location.

Market withdrawal: means a firm’s removal or correction of a distributed product which involves a minor violation that would not be subject to legal action by the FDA or which involves no violation.

Recall: means a firm’s removal or correction of a marketed product that the FDA considers to be in violation of the laws it administers and against which the agency would initiate legal action.

Recalling firm: means the firm that initiates a recall or, in the case of a Food and Drug Administration-requested recall, the firm that has primary responsibility for the manufacture and marketing of the product to be recalled.

Removal: means the physical removal of a device from its point of use to some other location for repair, modification, adjustment, relabeling, destruction, or inspection.

Risk to health: means (1) A reasonable probability that use of, or exposure to, the product will cause serious adverse health consequences or death; or (2) That use of, or exposure to, the product may cause temporary or medically reversible adverse health consequences, or an outcome where the probability of serious adverse health consequences is remote.

The FDA takes several steps to help and protect the people once a recall is initiated. Including; notifying the public, issuing a public warning and monitoring and auditing the recall.

What do I do if my Medication is Recalled?

Look at the recall information on the FDA website. There you will learn more about the reason for the recall and, in some cases, find instructions for what you need to do.

Call your pharmacist. They will have information and can advise you of what to do next. It may be as simple as exchanging your medication for tablet from a different lot. Any time you have questions or concerns about a medication, call your pharmacist first. They are better informed than the receptionist at your doctor’s office, and when it comes to medications, they often know more and know it sooner than your doctor.

Call your doctor. If your prescription medication has been recalled, you should call your doctor and find out if you need a different medication and how to go about switching safely.

Go to the emergency room if you are experiencing symptoms related to the recall and cannot reach your doctor right away, or if your symptoms are severe or potentially life-threatening.

What do I do if I am Harmed by a Medication?

When you or a loved one is injured by a medication that was supposed to make you feel better, you may be entitled to compensation. If you are taking a medication that has been recalled recently, you need to take notice of what is going on with it. The FDA will often issue a black box warning, which is one step short of a full recall on medication that may have caused harm. And while no amount of compensation can make up for the death of a loved one, you certainly think about filing a claim to cover any damages you deserve.

The information found on this website has been prepared for information purposes only; the information should not be construed as legal advice nor does the information imply any guarantee as to the results of future litigation. You should not act or rely upon this information without seeking formal professional counsel specific about your case. Carr & Carr Attorneys' offer to provide a free case evaluation is not intended to create an attorney-client relationship between Carr & Carr Attorneys and you.